May 10, 2019 – Federal Register Recent Federal Regulation Documents

DoD, GSA and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement a section of the National Defense Authorization Act for Fiscal Year 2018 to revise the definition of a ``commercial item.''

The preparation of an Environmental Impact Statement (EIS) for the Resource Management Plan (RMP) Revision for the Las Vegas and Pahrump Field Offices is hereby terminated.

The Environmental Protection Agency (EPA) will convene the Hazardous Waste Electronic System (``e-Manifest'') Advisory Board for a three (3) day public meeting to seek the Board's consultation and recommendations regarding the e-Manifest system (Meeting Theme: ``Increasing Adoption of the e-Manifest System'').

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.'' The purpose of this guidance is to assist sponsors in evaluating reproductive toxicity (mainly related to embryo-fetal development (EFD)) for anticancer pharmaceuticals and to provide recommendations to applicants for pharmaceutical labeling on duration of contraception following cessation of therapy to minimize potential risk to a developing embryo or fetus. The guidance also clarifies FDA's current thinking on when nonclinical studies for reproductive toxicology assessment may not be needed (e.g., for pharmaceuticals intended for use in postmenopausal women only). The intended outcome of this guidance is to facilitate the development of oncology pharmaceuticals while avoiding unnecessary use of animals, in accordance with the 3R (reduce, refine, replace) principles, and to provide a consistent approach to labeling recommendations for the duration of contraception after completion of therapy. This guidance finalizes the guidance of the same name issued September 29, 2017.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

This is a notice of an Economic Injury Disaster Loan (EIDL) declaration for the State of North Carolina, dated 04/30/2019. Incident: Gas Leak Explosion. Incident Period: 04/10/2019.

This document is being issued under the authority of the Atomic Energy Act of 1954, as amended. The Department is providing notice of a proposed subsequent arrangement under the Agreement for Co- operation between the Government of the United States of America and the Swiss Federal Council Concerning the Peaceful Uses of Nuclear Energy.

NextEra Energy Resources, LLC (NextEra), through its entity Mohave County Wind Farm, LLC, proposes to develop its Mohave County Wind Farm Project (Project) and interconnect it to Western Area Power Administration's (WAPA) Mead-Peacock 345-kilovolt (kV) transmission line. The Project site is located in the White Hills of Mohave County, Arizona, on lands managed by the U.S. Department of Interior, Bureau of Land Management (BLM) and Bureau of Reclamation (Reclamation). Based in part on the analysis in the final environmental impact statement (Final EIS), WAPA has determined to allow NextEra's request for interconnection to WAPA's transmission system on the Mead-Peacock 345- kV transmission line; to construct, own, operate, and maintain a new Project switchyard and associated communications equipment; and to replace or upgrade certain equipment in the Mead Substation to accommodate the Project.

The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995. This is the second notice for public comment; the first was published in the Federal Register, and no comments were received. NSF is forwarding the proposed submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice. The full submission may be found at: https://www.reginfo.gov/public/do/PRAMain.

In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on March 1, 2019 for information used to issue special flight authorizations for non-revenue transports and non-transport jet operations of Stage 2 airplanes at U.S. airports. Only a minimal amount of data is requested to identify the affected parties and determine whether the purpose for the flight is one of those enumerated by law. This collection is required under the Airport Noise and Capacity Act of 1990 and the FAA Modernization and Reform Act of 2012.

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

In accordance with the Federal Advisory Committee Act of 1972, the U.S. Geological Survey (USGS) is publishing this notice to announce that a Federal Advisory Committee meeting of the National Geospatial Advisory Committee (NGAC) will take place.

In compliance with the requirement for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Notice is hereby given of the following determinations: I hereby determine that the objects to be exhibited in the exhibition ``Treasures of Ancient Greece,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit objects at the Children's Museum of Indianapolis, Indianapolis, Indiana, from on or about June 15, 2019, until on or about January 5, 2020, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.

NMFS issues this final rule for the 2019 Pacific whiting fishery under the authority of the Pacific Coast Groundfish Fishery Management Plan, the Magnuson-Stevens Fishery Conservation and Management Act, and the Pacific Whiting Act of 2006. This final rule announces the 2019 U.S. Total Allowable Catch of 441,433 metric tons (mt) of Pacific whiting, establishes a tribal allocation of 77,251 mt, establishes a set-aside for research and bycatch of 1,500 mt, and announces the allocations of Pacific whiting to the non-tribal fishery for 2019. This final rule also amends the provisions regarding reapportionment of the treaty tribes' whiting allocation to the non- treaty sectors to require that NMFS consider the level of Chinook salmon bycatch before reapportioning whiting. This rule is necessary to manage the Pacific whiting stock to Optimal Yield, ensure that the Pacific Coast Groundfish Fishery Management Plan is implemented in a manner consistent with treaty rights of four treaty tribes to fish for Pacific whiting in their ``usual and accustomed grounds and stations'' in common with non-tribal citizens, and to protect salmon stocks listed under the Endangered Species Act. The catch limits in this rule are intended to ensure the long-term sustainability of the Pacific whiting stock.

In accordance with the Great Lakes Pilotage Act of 1960, the Coast Guard is establishing new base pilotage rates and surcharges for the 2019 shipping season. This rule will adjust the pilotage rates to account for a rolling ten-year average for traffic, and result in an increase in pilotage rates due to an adjustment for anticipated inflation, changes in operating expenses, surcharges for applicant pilots, and an addition of two pilots.

This final rule revises the Federal Health Insurance Programs for the Aged and Disabled by amending regulations for the Medicare Parts A, B, C and D programs, as well as the Medicaid program, to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC or list price) of that drug or biological product. This rule is intended to improve the efficient administration of the Medicare and Medicaid programs by ensuring that beneficiaries are provided with relevant information about the costs of prescription drugs and biological products so they can make informed decisions that minimize their out-of-pocket (OOP) costs and expenditures borne by Medicare and Medicaid, both of which are significant problems.

Notice is hereby given of the following determinations: I hereby determine that the objects to be exhibited in the exhibition ``Bauhaus Beginnings,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Getty Research Institute at the Getty Center, Los Angeles, California, from on or about June 11, 2019, until on or about October 13, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.

This action deletes a product and services to the Procurement List that were furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

The Coast Guard is proposing to establish a special local regulation for certain waters within Clear Lake, Clear Creek, TX. This action is necessary to provide safety of life on these navigable waters immediately before, during, and after the Texas Outlaw Challenge, a power boat race being held annually on the third Friday of June. This proposed rulemaking would prohibit persons and vessels not participating in the event from being within the specified zone unless authorized by the Captain of the Port Houston/Galveston (COTP) or a designated representative. We invite your comments on this proposed rulemaking.